A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects

Corcept Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CORT125134 dose to be determined; Drug: CORT125134 250 mg; Drug: CORT125134 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06094790

CORT125134-453

Details and patient eligibility

About

A study designed to characterize the plasma pharmacokinetic (PK) profile of CORT125134 in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134 for 14 days.

Full description

Initially, subjects will be enrolled into 2 cohorts each of 8 subjects (Cohort 1 and Cohort 2) to receive CORT125134 at 150 mg or 250 mg, respectively. Data from Cohorts 1 and 2 will be evaluated to select dose levels for Cohort 3 and optional Cohort 4.

The secondary objective of the study is to characterize the plasma PK profile of CORT125134 metabolites in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Give written informed consent
• Be healthy males or non-pregnant, non-lactating healthy females
• Must agree to use an adequate method of contraception as described in the study protocol
• Have a body mass index (BMI) of 18 to 32 kg/m^2, inclusive and body weight more than 50 kg (110 pounds)
• Be willing to comply with study restrictions as described in study protocol
• Be able to comply with the requirements of the entire study
• Be judged to be in good health, based on the results of medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory findings
• Have suitable veins for multiple venipuncture/cannulation

Exclusion criteria

• Be an employee or immediate family member of the Clinical Research Unit or Corcept
• Have been previously enrolled in this study
• Have multiple drug allergies, or be allergic to any of the components of study drug
• Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
• In the 1 year before study drug administration, have a history of drug or alcohol abuse
• In the 6 calendar months before study drug administration, on average: have smoked more than 5 cigarettes/day, consumed more than 14 units (female) or 21 units (male) of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor), consumed licorice or other glycyrrhetic acid derivatives regularly, in the judgement of the Investigator
• In the 2 calendar months before study drug administration, have donated/ lost blood or plasma in excess of 400 mL
• In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
• Have a positive test for alcohol or drugs of abuse at Screening or admission
• Have a positive test for exogenous glucocorticoids at Screening
• Have clinically-relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at Screening and/or before first dose
• Have any medical or social reasons for not participating in the study raised by their primary care physician
• Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
• Have taken any prohibited prior medication, as described in study protocol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Subjects will receive CORT125134 150 mg once daily for 14 days

Treatment:

Drug: CORT125134 150 mg

Cohort 2

Experimental group

Description:

Subjects will receive CORT125134 250 mg once daily for 14 days

Treatment:

Drug: CORT125134 250 mg

Cohort 3

Experimental group

Description:

Subjects will receive CORT125134 once daily for 14 days at a dose level decided based on evaluation of steady state exposure from Cohorts 1 and 2

Treatment:

Drug: CORT125134 dose to be determined

Cohort 4 (optional)

Experimental group

Description:

Subjects will receive CORT125134 once daily for 14 days at a dose level decided based on evaluation of steady state exposure from Cohorts 1, 2, and 3, if it is considered that this cohort would aid achievement of the study objectives

Treatment:

Drug: CORT125134 dose to be determined